Recall Z-1454-06 ยท CCH
Pointe Scientific, Inc.
Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma.
| Date | Aug 30, 2006 (initiated Jun 12, 2006) |
| Status | Terminated |
| Reason | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Root cause | Other |
| Action | Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email. |
| Quantity | To be determined |
| Distribution | Worldwide-USA and Greece, India, Korea, Lebanon, Pakistan, Poland, Singapore, Trinidad, Turkey, United Arab Emirates and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992002 | AUTOHDL CHOLESTEROL REAGENT SET Pointe Scientific, Inc.,, Aug 5, 1999 |